Policy & Regulation
Antibody Bamlanivimab Prevented COVID-19 in Nursing Homes and Reduced Risks by up to 80% for Residents
21 January 2021 - - Bamlanivimab (LY-CoV555), a human antibody discovered by Canada-based AbCellera (NASDAQ: ABCL) and developed with US-based Eli Lilly and Company (NYSE: LLY), significantly reduced the risk of contracting symptomatic COVID-19 among residents and staff of long-term care facilities, AbCellera said.

Lilly's Phase 3 BLAZE-2 COVID-19 prevention trial was conducted in partnership with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and the COVID-19 Prevention Network (CoVPN).

Key details from the BLAZE-2 study are as follows:

Participants were grouped based on their COVID-19 status at baseline: 965 COVID-19 negative participants (299 residents and 666 staff) were in the prevention group, and 132 COVID-19 positive participants (41 residents and 91 staff) were in the treatment group;

Participants in each group were randomized to receive either 4,200 mg of bamlanivimab or placebo;

Serious adverse events were reported at a similar frequency in both placebo and bamlanivimab groups, consistent with previous safety observations in Phase 1 and Phase 2 trials; Bamlanivimab reduced the risk of contracting COVID-19 by up to 80% in residents versus placebo (odds ratio 0.20; p=0.00026); and All deaths attributed to COVID-19 occurred in residents receiving the placebo. There were no COVID-19-related deaths of participants receiving bamlanivimab.

Bamlanivimab was developed from an antibody that was discovered from the blood of a recovered COVID-19 patient using AbCellera's pandemic response platform, in partnership with the Vaccine Research Center at NIAID.

Within one week of receiving the sample, AbCellera screened over five m antibody-producing cells to identify and isolate approximately 500 unique antibodies that bind to SARS-CoV-2, the virus that causes COVID-19.

The binding antibodies were then tested by AbCellera, the VRC, and Lilly to find those most effective in neutralizing the virus.

Bamlanivimab was selected as the lead candidate from this group of antibodies, and was the first therapeutic candidate specifically developed against SARS-CoV-2 to enter human clinical trials in North America.

Bamlanivimab was the first monoclonal antibody to receive Emergency Use Authorization from the US Food and Drug Administration and is currently being assessed in several clinical trials as both a monotherapy and in combination with other antibodies.

AbCellera's pandemic response capabilities were developed over the past two years as part of the Defense Advanced Research Projects Agency (DARPA) Pandemic Prevention Platform program.

The goal of the P3 program is to establish a robust technology platform for pandemic response capable of developing field-ready medical countermeasures within 60 days of isolation of an unknown viral pathogen.

AbCellera's ongoing efforts to respond to the pandemic have identified more than 2,300 unique anti-SARS-CoV-2 human antibodies from multiple patient samples.

These antibodies are in various stages of testing by AbCellera and its partners.

Bamlanivimab is a recombinant, neutralizing human IgG1 monoclonal antibody directed against the spike protein of SARS-CoV-2. It is designed to block viral attachment and entry into human cells, thus neutralizing the virus.

Bamlanivimab emerged from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19. Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at NIAID VRC.

It was identified from a blood sample taken from one of the first US patients who recovered from COVID-19.

Lilly has successfully completed a Phase 1 study of bamlanivimab in hospitalized patients with COVID-19 (NCT04411628). A Phase 2/3 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) is ongoing.

A Phase 3 study of bamlanivimab for the prevention of COVID-19 in residents and staff at long-term care facilities (BLAZE-2, NCT04497987) is ongoing. In addition, bamlanivimab is being tested in the National Institutes of Health-led ACTIV-2 study in ambulatory COVID-19 patients.

Bamlanivimab 700 mg is authorized in the US for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years and older with a positive COVID-19 test, who are at high risk for progressing to severe COVID-19 and/or hospitalization.

Bamlanivimab should be administered as soon as possible after a positive COVID-19 test and within 10 days of symptom onset.

AbCellera is a technology company that searches, decodes, and analyzes natural immune systems to find antibodies that its partners can develop into drugs to prevent and treat disease.

AbCellera partners with drug developers of all sizes, from large pharmaceutical to small biotechnology companies, empowering them to move quickly, reduce cost, and tackle the toughest problems in drug development.